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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Assurance Engineer III - Urology - **Company:** Boston, Inc. - **Location:** Minnetonka, MN, United States - **Experience:** Experienced - **Salary:** $82,100.0 - $156,000.0 - **Contract:** Permanent contract - **Skills:** Failure Mode Effects Analysis, Systems Integration - **Published:** July 8, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=88a95305f64a1cf5 ## About the Role * Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) * 3+ years of experience in design assurance, new product development or related medical device / regulated industry experience * Self-motivated with a passion for solving problems and a bias for action * Strong communication skills (verbal & written) * Demonstrated use of Quality tools/methodologies * Ability to effectively work and collaborate in a mixed onsite + remote environment * Demonstrated experience creating detailed technical documents Preferred qualifications: * Experience working with medical electrical equipment and/or active implantables * Quality Integration experience * ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis * Experienced problem solver, capable of facilitating the problem-solving process * Adaptable and effective collaborator in a team environment or in self-directed work * Experience with design changes, complaint reduction, and corrective action, This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors. As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Design Assurance Engineer III - Urologyposition require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Design Assurance Engineer III - Urology position. However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee's duties. ## Description This Design Assurance Engineer III position will work on the Valencia Technologies Integration project, specifically supporting product Design Control integration. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements., * Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. * Acts as an effective team member in supporting quality disciplines, decisions, and practices * Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes * Write various technical documentation for procedure execution, technical rationale, and evidence of the development process. * Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities * Support Post Market activities, as necessary, of risk based on post-market signals * Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed * Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards. * Support the verification, validation, and usability testing to meet or exceed internal and external requirements * Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints) * Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs) * Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. * Partner cross-functionally to identify and support value improvement efforts to support business goals ## Related Videos - [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build) - [AI Agents & Agentic AI](https://www.wearedevelopers.com/videos/2017-ai-agents-agentic-ai) - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) - [Physical AI: The Era of Intelligent Machines](https://www.wearedevelopers.com/videos/100141-physical-ai-the-era-of-intelligent-machines) - [Your next 10x engineer isn't in your city. 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